EB-OC is a tissue engineered osteochondral tissue graft comprising of a living tissue engineered cartilage layer attaching to a bone scaffold. The goal of this clinical trial is to learn about in the safety and efficacy of the EB-OC graft in participants who require repair of chondral/osteochondral defects of the knee. The main question it aims to answer is if the EB-OC graft works to regenerate osteochondral tissue comprising of native hyaline cartilage anchors to the regenerated bone. Participants will receive treatment of either the EB-OC Graft implantation in an arthrotomy procedure or abrasion chondroplasty. Researchers will compare results from the EB-OC graft to abrasion chondroplasty to assess overall safety and effectiveness.
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of adverse event incidents as compared to control
Timeframe: 12 months
Adverse event incident rate (% pateint) as compared to control
Timeframe: 12 months
Number of adverse events based on electrocardiogram readout as compared to control
Timeframe: Day 1, 1 week post Surgery
Incident rate of adverse event (% patient) based on electrocardiogram readout as compared to control
Timeframe: Day 1, 1 week post Surgery
Report of all adverse events including incidence, timing, severity, and relationship to the treatment
Timeframe: 36 months
Report of secondary surgical interventions
Timeframe: 36 months